Intra-Cellular Therapies, Inc.
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Latest From Intra-Cellular Therapies, Inc.
Keeping Track: Novel Orphan Drugs Amondys 45, Nulibry Clear US FDA; First-Line NSCLC Claim For Libtayo
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The company is on track to file an sNDA for lumateperone after a Phase III clinical trial met the primary endpoint in bipolar I and II disorder.
Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).
Public Company Edition: At the J.P. Morgan Healthcare Conference and Biotech Showcase it was noted that the US IPO market is likely to be less active in the second half of the year as election risk chills investment. Also, Apellis leads recent follow-on offerings.
- Drug Discovery Tools